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Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML

NCT07490288 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-16

No results posted yet for this study

Summary

This is a Phase I/II, single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in adult patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy.

The study plans to enroll 30 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.

Conditions

Interventions

DRUG

Venetoclax

BCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-9 or 3-14.

DRUG

Azacitidine

Hypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction.

DRUG

Liposomal Mitoxantrone

Liposomal topoisomerase II inhibitor. 24 mg/m² IV on day 1 of each induction cycle.

DRUG

Cytarabine

Antimetabolite. Consolidation: 2 g/m² (age \<60) or 1 g/m² (age ≥60) q12h IV on days 1-3 for 3 cycles.

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Recommended for high-risk or MRD+ patients after response.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-07-01
Completion
2029-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07490288 on ClinicalTrials.gov